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A Pilot Study to Assess the Efficacy and Safety of LCQ908 Alone and in Combination With Fenofibrate or Lovaza® in Patients With Severe Hypertriglyceridemia

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ClinicalTrials.gov Identifier: NCT01594983
Recruitment Status : Completed
First Posted : May 9, 2012
Last Update Posted : December 17, 2020
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Tracking Information
First Submitted Date  ICMJE May 7, 2012
First Posted Date  ICMJE May 9, 2012
Last Update Posted Date December 17, 2020
Study Start Date  ICMJE June 2012
Actual Primary Completion Date July 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 8, 2012)
Change from baseline in triglycerides (TG) relative to placebo at 6 weeks [ Time Frame: Baseline, 6 weeks ]
The dose response signal of 3 dose regiments of LCQ908 in patients at risk for non-FCS chylomicronemia as was measured by change from baseline in triglycerides (TG) relative to placebo at 6 weeks.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 2, 2012)
  • Change from baseline in triglycerides after adding LCQ908 to background therapy of fenofibrate or Fish Oil at 12 weeks [ Time Frame: Baseline, 12 weeks ]
  • Changes from baseline in triglycerides after treatment with LCQ908 monotherapy relative to fenofibrate or fish oil at 6 weeks [ Time Frame: Baseline, 6 weeks ]
  • Change from baseline in triglycerides after treatment with LCQ908 monotherapy relative to placebo at 12 weeks [ Time Frame: Baseline, 12 weeks ]
  • Number of patients in LCQ908 monotherapy with adverse events , serious adverse events and death [ Time Frame: 12 weeks ]
  • changefrom baseline in lipids and lipoprotein profiles [ Time Frame: Baseline, 6 weeks ]
Original Secondary Outcome Measures  ICMJE
 (submitted: May 8, 2012)
  • Change from baseline in triglycerides after adding LCQ908 to background therapy of fenofibrate or Fish Oil at 12 weeks [ Time Frame: Baseline, 12 weeks ]
  • Changes from baseline in triglycerides after treatment with LCQ908 monotherapy relative to fenofibrate or fish oil at 6 weeks [ Time Frame: Baseline, 6 weeks ]
  • Change from baseline in triglycerides after treatment with LCQ908 monotherapy relative to placebo at 12 weeks [ Time Frame: Baseline, 12 weeks ]
  • Number of patients in LCQ908 monotherapy with adverse events , serious adverse events and death [ Time Frame: 12 weeks ]
  • change from baseline in lipids and lipoprotein profiles [ Time Frame: Baseline, 6 weeks ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Pilot Study to Assess the Efficacy and Safety of LCQ908 Alone and in Combination With Fenofibrate or Lovaza® in Patients With Severe Hypertriglyceridemia
Official Title  ICMJE A Multicenter, Randomized, Active Comparator, Placebo Controlled, Double-blind Pilot Study to Assess the Efficacy and Safety of LCQ908 Alone and in Combination With Fenofibrate or Lovaza® in Patients With Severe Hypertriglyceridemia
Brief Summary This study is to determine a dose response signal for LCQ908 monotherapy and to assess the efficacy and safety of adding LCQ908 to Lovaza or fenofibrate.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Non Familial Chylocmicronemia Syndrome (Non-FCS)
Intervention  ICMJE
  • Drug: LCQ908
  • Drug: Fenofibrate
    Fenofibrate once daily 12 weeks
  • Drug: Fish Oil
    Fish Oil once daily for 12 weeks
    Other Name: Lovaza®
  • Drug: Placebo of LCQ908
    Matching placebo of LCQ908
  • Drug: Placebo of fenofibrate
    Matching placebo of fenofibrate
  • Drug: Placebo of fish oil
    Matching placebo of fish oil capsule
Study Arms  ICMJE
  • Experimental: LCQ908 1
    LCQ908 (Diacylglycerol acyltransferase inhibitor)once daily for 12 weeks
    Interventions:
    • Drug: LCQ908
    • Drug: Placebo of LCQ908
    • Drug: Placebo of fenofibrate
    • Drug: Placebo of fish oil
  • Experimental: LCQ908 2
    LCQ908 once daily for 12 weeks
    Interventions:
    • Drug: LCQ908
    • Drug: Placebo of LCQ908
    • Drug: Placebo of fenofibrate
    • Drug: Placebo of fish oil
  • Experimental: LCQ908 3
    LCQ908 once daily for 12 weeks
    Interventions:
    • Drug: LCQ908
    • Drug: Placebo of LCQ908
    • Drug: Placebo of fenofibrate
    • Drug: Placebo of fish oil
  • Active Comparator: Fenofibrate
    Intervention Type: Drug Intervention Name: Fenofibrate
    Interventions:
    • Drug: LCQ908
    • Drug: Fenofibrate
    • Drug: Placebo of LCQ908
    • Drug: Placebo of fish oil
  • Active Comparator: Fish Oil
    Fish oil once daily for 12 weeks
    Interventions:
    • Drug: LCQ908
    • Drug: Fish Oil
    • Drug: Placebo of LCQ908
    • Drug: Placebo of fenofibrate
  • Placebo Comparator: Arm Label: Placebo
    Intervention Type: other Intervention Name: other
    Interventions:
    • Drug: Placebo of LCQ908
    • Drug: Placebo of fenofibrate
    • Drug: Placebo of fish oil
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 29, 2013)
58
Original Estimated Enrollment  ICMJE
 (submitted: May 8, 2012)
60
Actual Study Completion Date  ICMJE July 2013
Actual Primary Completion Date July 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Male and female subjects ages >18 years of age, inclusive.
  • History of plasma TG concentration ≥890 mg/dl (10 mmol/L) or history of lactescent plasma in the fasting state.
  • Fasting TG ≥ 750 mg/dL (8.5 mmol/L) at day -7 or repeat of day -7 one week later for those failing to qualify initially and thought likely to qualify on repeat examination prior to randomization.

Exclusion Criteria:

  • Treatment with Omega-3 fatty acids or niacin or fibrates within 8 weeks of screening.
  • Patients with confirmed Familial Chylomicronemia Syndrome (FCS) with hyperlipoproteinemia (HLP) Type-I diagnosis or known to be homozygotes or compound heterozygotes for mutations in HLP Type I-causing genes (such as LPL, apoCII, CPIHBP1, or LMF1) prior to screening.
  • Pancreatitis within 3 months prior to screening.
  • Uncontrolled type 2 diabetes (T2DM) (as defined by an HbA1c value of ≥8.0% at screening)
  • BMI > 40 or history of bariatric surgery.
  • Nephrotic syndrome, Type 1 diabetes, HIV, HCV or HBV positive.
  • Estimated Glomerular Filtration Rate (eGFR) < 60 ml/min/1.73m2

Other protocol defined inclusion/exclusion criteria may apply

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   Russian Federation,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01594983
Other Study ID Numbers  ICMJE CLCQ908C2201
2012-000872-40 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Novartis ( Novartis Pharmaceuticals )
Study Sponsor  ICMJE Novartis Pharmaceuticals
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
PRS Account Novartis
Verification Date October 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP